Effect of Cyclosporine A Versus Tacrolimus on Response to Antiviral Therapy After Hepatitis C Gen… (NCT03665766) | Clinical Trial Compass
CompletedNot Applicable
Effect of Cyclosporine A Versus Tacrolimus on Response to Antiviral Therapy After Hepatitis C Genotype -4 Recurrence Post Liver Transplantation
126 participantsStarted 2014-05-15
Plain-language summary
Background and Aim: The immunosuppression influence on the response to antiviral therapy (AVT) for recurrent hepatitis C virus (HCV) infection in liver transplant (LT) recipients remains controversial, especially for the rarely investigated genotype 4.This study aims to compare the effects of the two widely used calcineurin inhibitors(CNIs)(Cyclosporine A (CsA) and tacrolimus (Tac)) on the therapeutic response to different AVT regimens. Method: In126 living donor liver transplant (LDLT) recipients with recurrent HCV infection, participants were categorized to three groups according to AVT. Group one received pegylated interferon (Peg IFN-α 2a) and ribavirin (RBV) (n= 44), group two received the direct antiviral agent (DAA) sofosbuvir plus RBV (n=52) and group three received daclatasvir, sofosbuvir (other DAAs) plus RBV(n=30) each group was further subdivided according to primary immunosuppression (CsA or Tac). The sustained virological response (SVR) and relapse rates were considered the primary therapeutic outcomes of AVT. The virological response guided therapy end points for AVT were considered the secondary outcomes.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:group(I):participants received Peg IFN-α 2a and RBV therapy who fulfilled the following inclusion criteria:
* Age between 18 and 65 years ;
* elevated aminotransferase levels (ALT and AST)
* detectable HCV RNA by polymerase chain reaction (PCR)
* liver biopsy results consistent with HCV recurrence using the Metavir scoring system (Metavir ≥A1F1)
* For group II and III:
* age between 18 and 75 years
* detectable HCV RNA by PCR
Exclusion Criteria:group I
* if they were younger than 18 years or older than 65 years or had one of the following criteria
* alcoholic
* poorly controlled autoimmune disease
* significant cardiac disease
* suicidal ideation
* a history of suicide attempt
* major psychosis
* serum creatinine ˃3 mg/dl
* thyroid dysfunction
* combined kidney-liver transplantation
* were currently pregnant or planning pregnancy.
Group II and III:
* younger than 18 years or older than 75 years
* total bilirubin (T.Bil) \>3 mg/dl
* serum albumin\< 2.8 mg/dl
* international normalized ratio ≥1.7
* Platelet count \< 5000/mm3
* HCC, except 4 weeks after intervention with no evidence of activity using computed tomography or magnetic resonance imaging
* extra hepatic malignancy except after two years of disease free-interval
* uncontrolled diabetes evidenced by glycated haemoglobin \>9%
* were pregnant .
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
sustained virological response
Timeframe: 24 weeks for group I and 12 weeks for group II and III